Recall Z-0992-2014 ยท FZX Guide, Surgical, Instrument
Synthes, Inc.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
| Date | Feb 19, 2014 (initiated Jan 27, 2014) |
| Status | Terminated |
| Reason | One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide. |
| Root cause | Process control |
| Action | A recall letter, dated January 27, 2014, was sent to end users and sales consultants. |
| Quantity | 12 |
| Distribution | US distribution to MI, TX, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.